[Ip-health] NY Times: Generic Smear Campaign

[Mike Palmedo]

http://www.nytimes.com/2006/05/09/opinion/09carlat.html

Generic Smear Campaign

New York Times
May 9, 2006
By DANIEL CARLAT
Op-Ed Contributor
Newburyport, Mass.

THAT pharmaceutical companies pay doctors to say good things about their
drugs is no longer newsworthy. Two former editors of The New England
Journal of Medicine, Jerome P. Kassirer and Marcia Angell, have
documented the drug industry's use of doctors to promote new medicines
through professional articles and at medical conferences.

But in a move that may astonish even the most jaded critics of ethically
challenged pharmaceutical marketing, makers of sleeping pills are now
paying doctors to publish bad things about competing drugs.

The market for sleeping pills is huge =97 42 million prescriptions were
filled last year =97 and it is more competitive than ever, thanks to the
recent introduction of Sepracor's Lunesta (the one with the butterfly
commercials), Sanofi-Aventis's Ambien CR (a controlled-release version
of Ambien) and Takeda Pharmaceuticals' Rozerem. Ads have made most of
these drugs household names. Yet many people have never heard of one of
the most widely prescribed hypnotics in the United States: trazodone.

First approved by the Food and Drug Administration 25 years ago,
trazodone is categorized as an antidepressant. Nonetheless,
psychiatrists prescribe it off label to treat insomnia, because it works
so well. Trazodone carries no risk of addiction; its half-life is long
enough to keep patients asleep all night; it has a long safety record;
and it is cheap, costing as little as 10 cents a pill. (Ambien and
Lunesta can cost $3 a pill or more.) And in the only sizable study to
compare trazodone with Ambien as a sleep aid, the two drugs performed
equally well.

But each time a psychiatrist prescribes trazodone, a potential sale of
Lunesta or Ambien is lost. No doubt that is why, in the past few years,
several articles have been published in professional journals that can
only be described as trazodone-bashing. With titles like "The Use of
Trazodone as a Hypnotic: A Critical Review" (published in The Journal of
Clinical Psychiatry), these articles purport to present balanced reviews
of the scientific literature on sleeping pills. But the authors,
psychiatrists with university affiliations, have been paid by Sepracor,
Sanofi-Aventis or Takeda, the companies that stand to gain from
trazodone's downfall.

A disclosure statement at the top of one such paper, "A Review of the
Evidence for the Efficacy and Safety of Trazodone in Insomnia," also in
The Journal of Clinical Psychiatry, states that Sepracor "assisted in
the preparation" of the article, and paid the author a fee for "the
services he provided in support of the development" of the manuscript.

A careful reading of these articles reveals a pattern of rhetorical
techniques: a minimization of trazodone's advantages and an emphasis on
its negative qualities.

Trazodone is criticized as lacking high-quality research data on its
ability to help people sleep. What is left unmentioned is that because
trazodone is no longer patented, no pharmaceutical company stands to
profit from doing such research.

The authors also dust off older studies highlighting side effects from
trazodone, like cardiac arrhythmias or priapism (prolonged painful
erections). But these side effects are extremely rare: priapism has been
found to occur in one in 5,000 men who take the drug, and the incidence
of cardiac arrythmias is even lower.

Case reports of such side effects inevitably surface when a drug has
been on the market for 25 years. In the case of Ambien, the oldest of
the newer drugs, we are already seeing a flurry of reports of problems
like drug abuse, sleepwalking, night eating and car accidents that may
be associated with its use.

The way to discourage this practice of negative marketing disguised as
legitimate scientific commentary is to mandate fuller disclosure of
links between drug companies and authors. Several states now insist that
drug makers report the gifts they give doctors.

These same companies should be required to disclose the exact nature of
a doctor's involvement in preparing a sponsored article, as well as the
dollar amount of his or her fee. I suspect it would be the rare doctor
who would want such information to come to light.

Daniel Carlat, a professor at Tufts Medical School, is the editor in
chief of The Carlat Psychiatry Report.